A.V. FISTULA NEEDLE SET— 510(k) K782021

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K782021 for A.V. FISTULA NEEDLE SET, Substantially Equivalent on 1979-03-21. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 1978-12-05
Decision date: 1979-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FIE

product code FIE

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.